How to Get Started

Registration to a management system standard and the continual improvement that follows is a joint effort between you and QMI – SAI Global. You will begin with implementing your management system and then partner with QMI – SAI Global to complete and maintain your registration.

Your EMS Implementation

Buy the Standard
You will need to purchase a copy of the standard you will be implementing.

Research
A good understanding of how other organizations have implemented and benefited from the ISO standards, plus any special requirements applicable to you, such as customer or industry requirements is necessary to support and motivate your decision to register.

Decision Time
Senior management must be committed in their support of your implementation of your chosen ISO standard(s) within the organization.

Management System Strategy
Before you begin the detail work of planning and implementing your management system, decide on its structure and consider whether it will cover one or multiple/all sites/departments and whether it will be managed centrally or independently. Also consider if you will integrate it with any other existing management systems.

Implementation Plan
There are a number of tasks you must do as you begin to implement your chosen management system standard, as well as any other management systems standard. First, you will need to have top management commitment to the implementation project. Top management must be available to lend support where needed in terms of the provision of resources, time, dollars, etc. and they must have full understanding of where the project will take the organization in the end.

Educating management and staff is the next step in the implementation process. They must understand and be aware of what the ISO 9001 standard is and consists of, what is involved in the scope of the project, and how it impacts the entire organization and their patients’/clients’ satisfaction with the service they receive.

Defining the key improvement objectives for the organization, as well as identifying and mapping out all organizational processes are the next steps and must have involvement from the departments and employees who actually perform those processes. From there, the organizations Quality Policy and Quality Manual are developed and a specific approach is established to ensure document control and access for all applicable personnel. Next, supporting documentation is developed and reviewed and then staff must be educated on all applicable documentation.

Finally, you must monitor and measure each of your processes, train internal auditors and implement an internal audit process, and conduct ongoing management review of your quality management system.

To help with the implementation phase of the project, you may want to seek the assistance of an experienced consultant in the healthcare industry who understands management systems and has worked with other health service providers in their pursuit of quality management systems registration. Please feel free to contact any of the industry consultants we have listed on our website.

NOTE: The consulting firms listed on the QMI – SAI Global website have demonstrated their ability to take companies through the registration process. QMI – SAI Global provides this list as a resource for our customers; however, this does not imply an endorsement of the performance of the consultant.

Create the plan to ensure you put controls in place to meet all the requirements of the standard, such as training, procedures and work instructions, maintenance, communications, audits, reviews and so forth.

Select a Registrar
Once the organization has fully implemented their quality management system through your chosen management system standard, a registrar should be chosen that is fully accredited to provide the registration services. Registering your quality management system provides assurance that the intent of the standard is actually being met by the organization. Your choice registrar should have experienced auditors in the healthcare sector who understand industry terminology and are expert lead auditors in the standards being registered.

QMI – SAI Global is uniquely positioned in that we understand what the healthcare industry needs in terms of management system standards and we have the knowledge and expertise to deliver beneficial and value-added audits to our clients within this industry. We have dedicated healthcare professionals who are ready to assist your organization in attaining higher standards of quality. We are also fully accredited with certified lead auditors from the healthcare field.

Call QMI – SAI Global today and complete a facility questionnaire.

Implementation
Complete the development of policies and procedures, launch an awareness campaign, and begin implementation of new practices. Talk to your QMI – SAI Global auditor!

Document Review and Preliminary Assessment
QMI – SAI Global will review your documented procedures to ensure they align properly with the Standard and come on-site to assess how well the implementation is progressing. You will be left with a report identifying areas to improve in preparation for the registration audit and agree to a registration audit date.

Review QMI – SAI Global Findings
Adjust your management system based on the findings from the document review and preliminary assessment.

Complete the Implementation of your Management System
You should aim to have your standard fully implemented for a minimum of three months so that sufficient information is available for an auditor to assess.

Conduct an Internal Audit and Management Review
An internal audit and management review are part of your management system and so need to be held in order to demonstrate full implementation of your standard (note that you will need to audit them separately after they have been held).

Registration Audit
QMI - SAI Global will provide you with an audit plan to guide you through the opening meeting, site tour, interviews, observations, records review, debriefings, and closing meetings. All the requirements of the ISO standard will be covered. We will issue you a final report.

Maintain and Improve your Management System
Work according to the practices defined by your standard and look for opportunities to improve your management system and performance. Remember, you can contact your QMI - SAI Global Auditor, Client Services Representative, or the Healthcare Product Manager at anytime.

Surveillance Audits
Similar to the registration audit, except it covers either approximately ¼ of your management system every 6 months or ½ of your management system every year with a focus on how well you are maintaining the standard.

R-Registration Audit
Similar to the registration and surveillance audits, it covers the entire standard with a focus on how well you are maintaining it.

A New ISO Certificate
QMI – SAI Global will conduct an internal independent review of your re-registration and issue your certificate after audit non-conformances, if any, have been resolved.